Supplier Quality Engineer I

Flexible & Integrated Technical Services, LLC • Villalba, PR

7d • Onsite

About The Position

This role is for Engineer services in the Manufacturing area. The ideal candidate will ensure that suppliers deliver quality parts, materials, and services. This includes qualifying suppliers according to company standards, potentially administering a Certified Supplier Program in receiving inspection for cost-effectiveness, and monitoring parts from acquisition through the manufacturing cycle. The role involves communicating and resolving supplier-related problems as they occur. Additionally, the position requires developing and prioritizing an auditing schedule to ensure designated suppliers are regularly audited for good manufacturing practices (GMP) and quality standards. Evaluating suppliers' internal functions to assess overall performance and providing feedback is also a key responsibility. Some individuals may have responsibilities that include Pre-Market Supplier Quality, providing Pre-Market Quality Engineering support to New Product Development (NPD) in partnership with Component Engineering and Post-Market Supplier Quality Teams to prevent defects and ensure high-quality, reliable products. This includes providing technical guidance and quality compliance for Supplier Quality engagement throughout the NPD lifecycle on newly qualified parts, implementing strategies for driving product quality and continuous improvement, and ensuring purchased products and components are manufactured and qualified according to applicable industry standards, regulatory requirements, and customer requirements. Collaboration with Component Engineers to develop and deliver the Product Acceptance Sampling Strategy, Approved Supplier List coordination, Supplier Owned Quality deployment, and Control Plans for new products is also expected. Defining Receiving Inspection requirements and associated test method validation for all internal Medtronic Test Methods is also part of the role.

Requirements

• Bachelor’s Degree in Engineering
• three (3) year of experience within the Medical Devices Industry
• Bilingual: Spanish and English
• Writing and communication skills
• Knowledge of GMP in a manufacturing environment
• Experience with equipment and process validation
• Ability to perform risk assessments and risk analysis

Responsibilities

• Ensures that suppliers deliver quality parts, materials, and services.
• Qualifies suppliers according to company standards and may administer a Certified Supplier Program in receiving inspection to ensure cost-effectiveness.
• Monitors parts from acquisition through the manufacturing cycle and communicates and resolves supplier-related problems as they occur.
• Develops and prioritizes an auditing schedule to ensure that designated suppliers are audited on a regular basis to ensure good manufacturing practices (GMP) and quality standards are met.
• Evaluates suppliers' internal functions to assess their overall performance and provides feedback in assessment of their operation.
• Provides Pre-Market Quality Engineering support to New Product Development (NPD) working in partnership with the Component Engineering and Post-Market Supplier Quality Teams, to deliver quality parts, materials, and services, prevent defects, and allow Medtronic to provide customers with the highest quality and reliable products.
• Provides technical guidance and quality compliance for Supplier Quality engagement throughout the NPD lifecycle on newly qualified parts from NPD and implementing strategies for driving product quality and continuous improvement, ensuring purchased products and components are manufactured and qualified in accordance to applicable industry standards, regulatory requirements, and customer requirements.
• Collaborates with Component Engineers to develop and deliver the Product Acceptance Sampling Strategy, Approved supplier List coordination, Supplier Owned Quality deployment, and Control Plans for new products.
• Define Receiving Inspection requirements as required and associated test method validation for all internal Medtronic Test Methods.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level